Events

Retiro De Equipo (Recall) de Xhibit Central Station (patient monitoring system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ecomed Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00572-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00572-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer, spacelabs, has received one report of values for patient height and weight being switched when input at the xhibit central station, causing a bedside monitor body surface area (bsa) calculation to be in error. no one has been injured due to this error. in order for the error to occur, the height and weight values must have been entered at the xhibit central station, the cardiac output cable must be attached for use, and the cardiac output function on the bedside monitor must be initiated. the bsa value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as cardiac index. the bedside monitor also contains a “drug calculator” for computation of drug dose conversions by weight or other units of measure. in situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition.
  • Acción
    Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction. This action has been closed-out on 27/01/2017.

Device

Xhibit Central Station (patient monitoring system)
  • Modelo / Serial
    Xhibit Central Station (patient monitoring system)Model Number: 96102Serial Numbers: SLA1114F00831, SLA0114F00450ARTG Number: 237776
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd